Prazosin Hydrochloride

Product NDC: 71610-046
Requested package NDC: 71610-046-80
11-digit product format: 716100046
Labeler code: 71610
Product ID: 71610-046_4c4ff07e-b724-4fe0-8d7b-aecd403e429a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prazosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA072575
Marketing category: ANDA
Marketing start: 2018-02-05
Marketing end: 0000-00-00
Substance: PRAZOSIN HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-046	71610-046-80	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A072575-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16
A072575-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16
A072575-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A072575-001	AB
A072575-002	AB
A072575-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072575-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072575-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-046-60	EA - Each	71610-046	c665efee-73b2-425f-969b-7f271f39eac5	1	2018-07-03
71610-046-80	EA - Each	71610-046	7cc86f93-3ae9-42e5-b03c-5e301fc941e4	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-046	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20180418_2f64ed95-03ea-41c7-959e-c2ddb5cf2dff.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	39e3fa5d-ea48-4b02-80f6-44591f5e013f	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Safecor Health LLC	12cdde5b-173c-4f31-a326-3128d521930c	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e5e129aa-2ee3-4c12-a327-5d5382cf2310	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5d7dff44-84b1-4044-bc5a-c76ea11dd5a3	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cd52f022-ca29-4f87-8684-da63e05b3c1f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Mylan Institutional Inc.	e6a029b2-802f-4cc5-8795-20e177e8d779	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0	2023-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1ce90aaf-d075-4617-9a47-e8d922096d23	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X0Z7454B90	PRAZOSIN HYDROCHLORIDE	19237-84-4	PRAZOSIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-046-80	71610004680	180 CAPSULE in 1 BOTTLE, PLASTIC (71610-046-80)	180 capsule	2018-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2018-04-06	HUMAN PRESCRIPTION DRUG LABEL	1